Trial Condition(s):
Contraception
YAZ, Oral Contraceptive registration in China
Bayer Identifier:
91619
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
The purpose of this study is to evaluate the effectiveness in terms of prevention of pregnancy and safety of the oral contraceptive YAZ in healthy Chinese women.
Inclusion Criteria
-Healthy women between 18 and 45 requesting oral contraception. -Smokers may not exceed 30 years of age.
Exclusion Criteria
-The use of steroidal oral contraceptives , or any drug that could alter oral contraception metabolism will be prohibited during the study. -Pregnancy, lactation (less than 3 menstrual cycles since delivery, abortion or lactation before start of treatment) -Menstrual disorders suspicious of ovarian failure (e.g. oligomenorrhea, amenorrhea, hypomenorrhea -Any disease or condition that may worsen under hormonal treatment -Other contraceptive methods such as sterilization or IUD/IUS -Substantial overweight (BMI > 30 kg/m2).
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Peking University First Hospital Beijing, China, 100034 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Chongqing Medical University Second Hospital Chongqing, China, 400010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tongji Hosp Tongji Med College of Huazhong University of Sci Wuhan, China, 430022 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Xijing Hospital, the 4th Military Medical University Xi An, China, 710032 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Southeast University affilitated Zhongda Hospital Nanjing, China, 210009 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Obs. and Gyn. Hospital of Medical Center of Fudan Univer Shanghai, China, 200011 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Shanghai second Medical University, Shanghai Ren Ji Hospital Shanghai, China, 200127 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Peking University People's Hospital Beijing, China, 100044 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations West China Second University Hospital of Sichuan University Chengdu, China | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations 1st hospital of Chongqing Medical University Chongqing, China | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Shengjing Hospital of China Medical University Shenyang, China, 110004 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Qi Lu hospital of Shandong University Jinan, China | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Third Affiliated Hospital of Sun Yat-sen University Guangzhou, China | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nanjing First Hopital Nanjing, China, 210006 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Subei People's Hospital of Jiangsu Province Yangzhou, China, 225001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Second Affiliated Hospital of Sun Yat-sen University Guangzhou, China, 510120 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Queen Mary Hospital, University of Hong Kong Hongkong, Hong Kong, China | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A multicenter, open-label, single-arm study to investigate the efficacy and safety of the oral contraceptive YAZ (20 μg ethinylestradiol, 3 mg drospirenone) for 13 cycles in 670 healthy Chinese female volunteers.
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Prevention
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- The primary efficacy variable is the number of unintended pregnancies as measured by the Pearl Index (PI) during 13 cycles of treatment.Timeframe: 13 cycles (1 cycle= 28 days)
Secondary Outcome
- Bleeding pattern indicesTimeframe: 13 cycles
- Cycle control parametersTimeframe: 13 cycles
- Adverse eventsTimeframe: Whole study period
- Laboratory testsTimeframe: Whole study period
Additional Information
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